Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115AM1)(COMPLETED)

This study has been completed.

Study NCT00686543 Information provided by Schering-Plough

First Received on May 27, 2008. Last Updated on July 2, 2010 History of Changes

Results First Received: April 15, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Fungal Infection Acute Myelogenous Leukemia Neutropenia
Intervention:	Drug: Posaconazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Not Randomized	Posaconazole oral suspension (POS) 200 mg Three Times a Day (TID) on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8)
POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15	POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15	POS 200 mg TID on Days 1-8 followed by POS 400 mg Twice a Day (BID) on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15	POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).

Participant Flow: Overall Study

	Not Randomized	POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15	POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15	POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15
STARTED	14	21	20	20
COMPLETED	0	20	15	17
NOT COMPLETED	14	1	5	3
Adverse Event	9	1	3	2
Withdrawal by Subject	2	0	0	0
Protocol Violation	3	0	2	1

Baseline Characteristics

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Reporting Groups

	Description
Not Randomized	POS 200 mg TID on Days 1-8, administered with food or oral nutritional supplements (participants who discontinued anytime before randomization on Day 8).
POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15	POS 200 mg TID on Days 1-8 Followed by POS 200 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to continue with POS 200 mg TID on Days 9-15).
POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15	POS 200 mg TID on Days 1-8 followed by POS 400 mg BID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg BID on Days 9-15).
POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15	POS 200 mg TID on Days 1-8 followed by POS 400 mg TID on Days 9-15, administered with food or oral nutritional supplements (participants who received POS 200 mg TID on Days 1-8 and were then randomized to POS 400 mg TID on Days 9-15).

Baseline Measures

	Not Randomized	POS 200 mg TID Days 1-8 Followed by POS 200 mg TID Days 9-15	POS 200 mg TID Days 1-8 Followed by POS 400 mg BID Days 9-15	POS 200 mg TID Days 1-8 Followed by POS 400 mg TID Days 9-15	Total
Number of Participants [units: participants]	14	21	20	20	75
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	11	16	16	19	62
>=65 years	3	5	4	1	13
Gender [units: participants]
Female	6	10	11	9	36
Male	8	11	9	11	39

Outcome Measures

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1. Primary:

Mean POS Plasma Concentrations on Days 2, 3, and 8. [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 2, 3, and 8 ]

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2. Primary:

Mean POS Plasma Concentrations on Days 8 and 15 Stratified by Randomized Dosing Regimen [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ]

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3. Primary:

Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 3 and ≥/<500 ng/mL on Day 8 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8 ]

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4. Primary:

Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 3 and ≥/<700 ng/mL on Day 8 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 3 and 8 ]

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5. Primary:

Participants With a Mean POS Plasma Concentration ≥/<250 ng/mL on Day 8 and ≥/<500 ng/mL on Day 15 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ]

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6. Primary:

Participants With a Mean POS Plasma Concentration ≥/<350 ng/mL on Day 8 and ≥/<700 ng/mL on Day 15 [ Time Frame: Predose (0 hour) and 5 hours postdose on Days 8 and 15 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The sponsor and investigator will publish/present study results together with other study sites, unless written permission is obtained. The investigator provides to the sponsor 45 days prior to submission for publication/presentation, copies of abstracts or manuscripts reporting any study results. The sponsor has the right to review/comment on the data analysis and presentation regarding proprietary information, accuracy and fair blance of the information, and compliance with FDA regulations.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00686543 History of Changes
Other Study ID Numbers:	P05115, EudraCT No. 2007-003148-31
Study First Received:	May 27, 2008
Results First Received:	April 15, 2010
Last Updated:	July 2, 2010
Health Authority:	United States: Food and Drug Administration